BEUDAMED
    FDA Registration Active 🇨🇳 China

    SUZHOU ENNOVA ELECTRONIC TECHNOLOGY CO LTD

    Reg #: 3000947648 · FEI: 3000947648 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SUZHOU ENNOVA ELECTRONIC TECHNOLOGY CO LTD
    Registration Number
    3000947648
    FEI Number
    3000947648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    The 3rd Floor, Building 2#, No. 1875 Zhong Huayuan West Road, Yushan Town, Kunshan District
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152648

    Owner / Operator

    Firm Name
    Suzhou Ennova Electronic Technology Co Ltd
    Operator Number
    10051270
    Address
    The 3rd Floor, Building 2#, No. 1875 Zhong Huayuan West Road, Yushan Town, Kunshan District
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215300
    Country
    CN
    Correspondent
    Jianguang Huang

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Self-adhesive Electrode Electrocardiograph electrode

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device